Orudis

NDA 18754, held by Wyeth Ayerst. Ketoprofen.

As of Nov 13, 2026, NDA 18754 (Orudis), held by Wyeth Ayerst, was first approved by FDA on Jan 9, 1986, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 9, 1986
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jan 6, 1994	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 31, 1987	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 9, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms

Product	Active ingredient	Marketing
Orudis25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Ketoprofen	DiscontinuedReference drug
Orudis50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Ketoprofen	DiscontinuedReference drug
Orudis75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Ketoprofen	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 18, 2006	Supplement 27Labeling · Standard review	Approved	Letter
Aug 18, 2003	Supplement 26Labeling · Standard review	Approved	Letter
Aug 5, 1997	Supplement 25Labeling · Standard review	Approved	Review
Feb 17, 1995	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 24Labeling · Standard review	Approved	None posted
Jul 11, 1994	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 11, 1994	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 6, 1994	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 5, 1990	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 16, 1990	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 5, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 5, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 10, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 11, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 26, 1988	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 18, 1988	Supplement 11Labeling · Standard review	Approved	None posted
Jul 31, 1987	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 31, 1987	Supplement 4Labeling · Standard review	Approved	None posted
Jul 23, 1987	Supplement 7Labeling · Standard review	Approved	None posted
Mar 17, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 16, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 27, 1986	Supplement 1Labeling · Standard review	Approved	None posted
Jan 9, 1986	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 18754
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters